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Cleanroom Testing and Monitoring
Cleanroom Testing and Monitoring
Cleanroom Testing
and Monitoring
Bench-mark:
establish the initial performance of the room to
compare the results of routine check or contamination
problem in the future.
initial test
Time
been built/ going to hand over/ reopen
Tested standards
ISO 14644-1.
Monitoring
to regularly check the room at the time
intervals set by ISO 14644-2
Quality:
the air will not add significantly to the contamination
within the room
Cleanroom Tests
Additional tests
temperature
relative humidity
heating and cooling capabilities of the room
sound levels
lighting levels
vibration levels.
requirements
Guides provided by
the American Society Heating Refrigeration
and Airconditioning Engineers (ASHRAE) in
the USA, and
the Chartered Institute of Building Services
Engineers (CIBSE) in the UK.
Re-testing to Demonstrate
Compliance
The cleanroom
checked
intervals, these
intervals being
more frequent
in higher
specified
rooms: ISO
14644-2
Monitoring of Cleanrooms
Use risk assessment to decide what monitoring
tests should be done and how often. The
variables that are most likely to be monitored
are:
air pressure difference
This might be necessary in high quality cleanrooms such as
ISO Class 4, and better.
Purpose
A cleanroom must have sufficient clean air
supplied to dilute and remove the airborne
contamination generated within the room.
Air Cleanliness:
Turbulently ventilated cleanroom
air supply; the more air supplied in a given time, the cleaner
the room.
unidirectional cleanroom
air supply velocity
Test:
Initial testing of the design
Regular intervals check
Air Quantities
Instruments:
Hoods: air supply
volumes
Anemometers: air
velocities
Turbulently ventilated
rooms
measured within the
air conditioning
ducts Pitot-static
tube
Anemometers
Anemometers: away from the filter of
about 30cm (12 inches)
Vane Anemometer
Principle: Air supply turning a vane
frequency velocity
Accuracy: velocity is less than about 0.2 m/s
(40 ft/min), the mechanical friction affects the
turning of the vane
Vane Anemometer
Thermal Anemometers
Principle: Air passing
through the head of
the instrument
cooling effect the
air velocity: Fig.10.3 :
a bead thermistor (
)
Low velocities can be
measured with this
type of apparatus
Large openings:
problems can occur when trying to achieve a
pressure difference between areas connected
by large openings, such as a supply tunnel. To
achieve the suggested pressure drop :
Very large air quantities through the tunnel
To accept a lower pressure difference
Inclined manometer
works by pressure
pushing a liquid up an
inclined tube.
small pressure
changes in the inclined
tube up to a pressure
of about 60 Pa.
After that pressure, the
tube moves round to
the vertical measuring
pressure differences
can be in the 100 to
500 Pa range.
Purposes
To show that a cleanroom is working
correctly, it is necessary to demonstrate
that no contamination infiltrates into the
cleanroom from dirtier adjacent areas.
Cleanroom Containment Leak Testing
Airborne contamination: doors and hatches,
holes and cracks in the walls, ceilings and
other parts of the cleanroom fabric
ceiling-to-wall interface
filter and lighting housings-to-ceiling interfaces
ceiling-to-column interface
the cladding of the ceiling support pillars
Service plenums and the entry of services into
the cleanroom: electrical sockets and switches,
and other types of services providers.
Particularly difficult to foresee and control in a
negatively pressurized containment room.
Difficulty
where the containment originates from may
be unknown, and it is often difficult to find the
places to release test smoke.
Streamers
Ch. 12
Filter Installation Leak Testing
HEPA test
Manufacturer's factory and packed OK
Unpacked and fitted into the filter housings
maybe damage
Leakage problems
casing
housing
Di-octylsebacate (DOS)
Laskin nozzle
Air+
oil particle
0.5 m
Air pump
oil
vaporize
oil smoke
condense
aerosol
0.3 m
Semiconductor manufacturing
'outgassing'
chemical products harmful to filter
Polystyrene Latex Spheres (PLSs)
(0.1 ~ 1m)
Single particle
counters
sample a volume of
air and this is
collected in a set time
Repair of leaks
Filter media leak
at the fold of the paper
repaired on site with
silicon
replaced
Ch. 13
Airborne Particle Counts
Cleanroom test
air supply volume,
pressure differences,
air movement within and between
cleanrooms,
filter integrity
airborne particle concentration
Particle counter
Particle counter : both counts
and sizes
Photometer : mass of particles
Particle Counter
Check:
p-counter.pdf
Opc-8240.pdf
Measurement of Particle
Concentrations (ISO 14644-1)
Principles: The number of sampling
locations must reflect the size of the room
and its cleanliness.
The methods: (a) number of sampling
locations and (b) the minimum air volume
NL A
Example
4m x 5m size. ISO Class 3 in the 'as built'
condition at a particle size of >= 0.1 m.
Number of locations
A= 4m x 5m. N = 4x5 = 4.475
The minimum number of locations is 5
Calculation of 95%UCL
the 'means of averages': M
M = (580+612+706+530+553)/5 = 596
s.d
i 1
(Xi M )
N 1
Membrane filtration
A membrane filter is mounted in a
holder vacuum draw air microbecarrying will be filtered out by membrane
The membrane placed an agar plate
A membrane filter with a grid printed on
the surface will assist in counting the
micro-organisms.
Contact Slides
Swabbing
uneven surfaces: bud
swab rubbed surface
and then rubbed over
an agar plate.
Personnel sampling
Personnel are the primary source of microorganisms in a cleanroom.
The methods commonly used are:
Finger dabs.
The person's fingers tips, or their gloved hand, is pressed or wiped
on an agar plate and the number of micro-organisms ascertained.
Body box.
If a person wearing normal indoor clothing exercises within a body
box their dispersion rate of airborne micro-organisms can be
ascertained.
Dip
Slide
15.
Operating a Cleanroom:
Contamination Control
Purpose
considering the sources and routes of
contamination within a cleanroom and how
to control these.
Control contamination
assessing risk during manufacturing: such
as Fault Tree Analysis (FTA) and Failure
Mode and Effect Analysis (FMEA).
(Electrical and mechanical systems)
Documentation
An effective contamination control system will
document
(1) the methods described in the preceding
steps of this chapter,
(2) the monitoring procedures, and
(3) results from the monitoring.
Regular reports should be issued of an analysis
of the monitoring results and any deviations from
the expected results.
Staff Training
They first arrive at the cleanroom
Train at regular intervals throughout their
careers.
Personnel
source of contamination
micro-organisms
particles and fibres
Prohibited items:
food, drink, sweets and chewing gum
cans or bottles, smoking materials
radios, CD players, Walkmans, cell phones,
pagers, etc.
newspapers, magazines, books and paper
handkerchiefs
pencils and erasers
wallets, purses and other similar items.
Personnel behaviour
No Silly behaviour: The generation of
contamination is proportional to activity.
motionless: 100,000 particles >=0.5 m/min
head, arms and body moving: 1,000,000 particles >= 0.5
mm/min
walking: 5,000,000 particles >= 0.5 m/min
Personnel product
position themselves correctly
not lean over the product;
working in unidirectional air: not between
the product and the source of the clean
air, i.e. the air filter.
'No-touch' techniques should be devised:
from gloved hand onto the product.
Handling materials
The movement of materials between the
inside and outside of a cleanroom should
be minimized.
Waste material: collected frequently into
easily identified containers and removed
frequently from the cleanroom.
Pre-change zone
street or factory clothes removed
Watches and rings removed. Items such as cigarettes and
lighters, wallets and other valuables should be securely stored.
Remove cosmetics and apply a suitable skin moisturizer (no
chemicals used in the formulation cause contamination
problems in the product being manufactured)
Put on a pair of disposable footwear coverings, or change into
dedicated cleanroom shoes.
wash the hands, dry them and apply a suitable hand lotion.
Cross over from the pre-entry area into the change zone.
Changing zone
The garments to be worn are
selected.
A facemask and hood (or cap) is
put on
Temporary gloves known as
'donning gloves' are sometimes
used
The coverall (or gown) should be
removed from its packaging and
unfolded without touching the floor.
goggle
For manufacturing
Packaging for the product
Process machinery and equipment
Tools used for the maintenance,
calibration or repair of equipment and
machinery;
Clothing for personnel, such as suits,
gloves and masks;
Prohibited material:
abrasives or powders;
aerosol-producing cans or bottles;
items made from wood, rubber, paper, leather,
wool, cotton and other naturally occurring
materials that break up easily;
items made from mild steel, or other materials
that rust, corrode or oxidise;
Entry of Machinery
Machines, and other heavy and large bulky
items of equipment, are occasionally taken in
or out of a cleanroom.
The best solution to the movement of bulky
items is to design the materials airlock to be
large enough to allow the entry and exit of
every piece of machine to be brought in or out
of the room.
Sources and routes of particles and microbe containing particles from people
Cleanroom clothing
synthetic plastic materials: such as
polyester or nylon.
In a higher standard
of cleanroom a onepiece zip-up coverall,
knee-high overboots
and a hood that tucks
under the neck of the
garment will be typical
Cleanroom fabrics
Garment construction
To prevent the raw edges
To minimise shedding, the zippers,
fasteners and shoe soles should not chip,
break up or corrode.
Choice of garments
IEST Recommended Practice RP-CC-003.2.
R = recommended
NR == not recommended
AS = application specific
(NR*) = not recommended in nonunidirectional
flow
Table 19.2 Garment systems for aseptic cleanrooms (IEST RP CC003.2)
Processing of Cleanroom
Garments and Change Frequency
Processing
to be reused cleanroom laundry antistatic
treatment and disinfection or sterilisation
Frequency of change
semiconductor industry ( the highest specification),
changed once or twice a week.
fresh garments are put on every time personnel
move into an aseptic pharmaceutical production
area.
Face masks
surgical-style with
straps and loops:
disposable surgicaltype
Cleanroom Gloves
Hand contamination and gloves
There are two types of gloves associated with
cleanrooms.
Knitted or woven gloves are used for lower
classes, i.e. ISO Class 7 (Class 10,000) and
poorer areas, as well as undergloves. The knit or
weave should be tight and a number of loose
threads minimised.
Barrier gloves, which have a continuous thin
membrane covering the whole hand are used in
the majority of cleanrooms.
Types of gloves
Polyvinyl chloride (PVC) gloves
Latex Gloves
Other Polymer Gloves
Latex Gloves
This is the type used by surgeons, and the 'particle-free' type is now
used in cleanrooms. Latex gloves can be produced 'powder-free',
and those gloves that are washed further by use of filtered,
deionised water are often used in ISO Class 4 (Class 10) or ISO
Class 3 (Class 1) cleanrooms.
They have good chemical resistance, giving protection against most
weak acids and bases, and alcohols, as well as having a fairly good
resistance against aldehydes and ketones.
They are slightly more expensive to buy than the PVC type, but
cheaper than any other polymer. They can be sterilised. Because of
their elasticity, the glove can securely incorporate the cuff of a
garment under the sleeve.
Polythene gloves
are strong, very thin, quite inflexible, and expensive. They may be manufactured with
microporous material for better comfort, or with carbon in the formulation which makes them
conductive.
PVA gloves
are chemically similar to latex gloves, but have the advantage of having a better resistance
to solvents than latex gloves. They are slightly more expensive than latex.
Polyurethane gloves
are used in cleanrooms and have the advantage of being free of oils and additives, as well
as resistant to puncturing. They are not resistant to aliphatic solvents. The main drawback of
this glove type is that they are constructed from float sheets and the seams are welded.
Manual dexterity is reduced with these gloves.
are resistant to strong acids and solvents, but not water in which they are soluble. They are
expensive.
Gore-Tex gloves
have welded seams and are hypoallergenic. They are breathable because of their porous
membrane. They are expensive.
Vacuuming
Dry vacuuming :
depends on a jet of air moving towards the vacuum
nozzle and overcoming the adhesion forces of
particles to the surface
Figure 21.1 : efficiency of dry vacuuming against
different sizes of sand particles on a glass surface.
Wet -wiping
Wet wiping, with wipers or mops, can
efficiently clean cleanroom surfaces. The
liquid used allows some of the particle-tosurface bonds to be broken and particles to
float off.
Tacky rollers
The particle removal efficiency of 'tacky'
rollers is dependent on the strength of the
adhesive force of the roller's surface.
Mopping systems
mops for cleanroom:
materials that do not easily
break up: PVA or
polyurethane open-pore
foam, or a fabric such as
polyester.
The compatibility of the
material to sterilization,
disinfectants and solvents
should be checked
Buckets should be made
from plastic or stainless
steel.
Wipers
Purpose: wipe surfaces and remove contamination; to
wipe contamination from products produced; used dry
to mop-up liquids that may have been spilled.
Sorbency
Sorbency is an important property of wipers. Wipers are
often used to mop up a spillage and other similar tasks.
Tacky rollers
Tacky rollers are
similar in size and
shape to paint rollers
used in the home, but
they have a tacky
material around the
outside of the roller. An
example of a tacky
roller is shown in
Figure 21.7.